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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Valve in Cartridge, 9mm
Gyrus Acmi, Inc.
HUS-V9
In Commercial Distribution

  • 00896506002200 ()

  • Outer Diameter: 9 Millimeter


  • Endobronchial valve
Valve in Cartridge, 7mm
Gyrus Acmi, Inc.
HUS-V7
In Commercial Distribution

  • 00896506002101 ()

  • Outer Diameter: 7 Millimeter


  • Endobronchial valve
Valve in Cartridge, 6mm
Gyrus Acmi, Inc.
HUS-V6
In Commercial Distribution

  • 00896506002095 ()

  • Outer Diameter: 6 Millimeter


  • Endobronchial valve
Valve in Cartridge , 5mm
Gyrus Acmi, Inc.
HUS-V5
In Commercial Distribution

  • 00896506002088 ()

  • Outer Diameter: 5 Millimeter


  • Endobronchial valve
This product is an over-the-counter powered exerciser emitting very bright light.
KBL GmbH
T3/50-180-c
In Commercial Distribution

  • 04260489020180 ()


  • Vibration platform exerciser, stationary
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-5.5-LP
In Commercial Distribution

  • 00811907030423 ()

  • Bronchial Diameter Range of 5.5-8.5 mm


  • Endobronchial valve
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-5.5
In Commercial Distribution

  • 00811907030324 ()

  • Bronchial Diameter Range of 5.5-8.5 mm


  • Endobronchial valve
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-4.0-LP
In Commercial Distribution

  • 00811907030225 ()

  • Bronchial Diameter Range 4.0-7.0 mm


  • Endobronchial valve
The Zephyr® Endobronchial Valve (Zephyr Valve) is an endobronchial implant designed to occlude airflow in the target lobe and thereby reduce lung volume. The device consists of a one-way silicone duckbill valve attached to a nickel-titanium (Nitinol) self-expanding retainer that is covered with a silicone membrane. It is implanted in the target bronchus during a bronchoscopy procedure using the Zephyr Endobronchial Delivery Catheter (EDC) that is guided to the targeted bronchus by inserting it through the working channel of an adult bronchoscope. Successful lobar occlusion may require placement of multiple Zephyr Valves in bronchi of the target lobe. The Zephyr Valves permit air to vent out of the treated lobe during exhalation but do not permit refilling of this region during inhalation to reduce hyperinflation due to emphysema. Trapped air in the diseased lobe escapes through the Zephyr Valves until the lung volume of the treated lobe is reduced. The Zephyr Valve is designed to be a permanent implant, but can be removed, if necessary.
PULMONX CORPORATION
EBV-TS-4.0
In Commercial Distribution

  • 00811907030126 ()

  • Bronchial Diameter Range of 4.0-7.0 mm


  • Endobronchial valve
No Description
JK-Products GmbH
JK 194/RV32-10 VBR
In Commercial Distribution

  • EJKP100003973A0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 98 / RV 30-0 VBR E
In Commercial Distribution

  • EJKP100003960B0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 98 / BA VBR E
In Commercial Distribution

  • EJKP100003960A0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 194/RV32-0 VBR
In Commercial Distribution

  • EJKP100003952B0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 158 / BA VBR
In Commercial Distribution

  • EJKP100003952A0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 98 / BA VBR E
In Commercial Distribution

  • EJKP100003772A0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 158 / BA VBR
In Commercial Distribution

  • EJKP100003443A0 ()


  • Vibration platform exerciser, stationary
No Description
JK-Products GmbH
JK 98 / BA VBR
In Commercial Distribution

  • EJKP100003194A0 ()


  • Vibration platform exerciser, stationary
Chin Implant
IMPLANTECH ASSOCIATES, INC.
Style 2 / Size 2
In Commercial Distribution

  • M724CH221 ()
CH 2-2

  • Chin prosthesis
Tibial Component, All-Poly PS
WALDEMAR LINK GmbH & Co. KG
880-414/22
In Commercial Distribution

  • 04026575258796 ()
880-414/22

  • Uncoated knee tibia prosthesis, polyethylene
Tibial Component, All-Poly PS
WALDEMAR LINK GmbH & Co. KG
880-413/22
In Commercial Distribution

  • 04026575258734 ()
880-413/22

  • Uncoated knee tibia prosthesis, polyethylene
Tibial Component, All-Poly PS
WALDEMAR LINK GmbH & Co. KG
880-412/22
In Commercial Distribution

  • 04026575258673 ()
880-412/22

  • Uncoated knee tibia prosthesis, polyethylene
Tibial Component, All-Poly PS
WALDEMAR LINK GmbH & Co. KG
880-411/22
In Commercial Distribution

  • 04026575258604 ()
880-411/22

  • Uncoated knee tibia prosthesis, polyethylene
Tibial Augment
WALDEMAR LINK GmbH & Co. KG
880-339/22
In Commercial Distribution

  • 04026575258543 ()
880-339/22

  • Knee arthroplasty wedge
Tibial Augment
WALDEMAR LINK GmbH & Co. KG
880-337/22
In Commercial Distribution

  • 04026575258420 ()
880-337/22

  • Knee arthroplasty wedge
Tibial Augment
WALDEMAR LINK GmbH & Co. KG
880-335/22
In Commercial Distribution

  • 04026575258369 ()
880-335/22

  • Knee arthroplasty wedge
Tibial Augment
WALDEMAR LINK GmbH & Co. KG
880-333/22
In Commercial Distribution

  • 04026575258307 ()
880-333/22

  • Knee arthroplasty wedge
Tibial Augment
WALDEMAR LINK GmbH & Co. KG
880-331/22
In Commercial Distribution

  • 04026575258246 ()
880-331/22

  • Knee arthroplasty wedge
Femoral Augment, L-Shaped
WALDEMAR LINK GmbH & Co. KG
880-321/22
In Commercial Distribution

  • 04026575258079 ()
880-321/22

  • Knee arthroplasty wedge
Femoral Augment, L-Shaped
WALDEMAR LINK GmbH & Co. KG
880-320/22
In Commercial Distribution

  • 04026575258055 ()
880-320/22

  • Knee arthroplasty wedge
Femoral Augment, Posterior
WALDEMAR LINK GmbH & Co. KG
880-319/22
In Commercial Distribution

  • 04026575257973 ()
880-319/22

  • Knee arthroplasty wedge
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